DOH Cites Mt. Sinai Medical Center for Deficient Care in Living Liver Donor Death

$48,000 Fine Levied Following Department Investigation

New York City, March 12, 2002 — State Health Commissioner Antonia C. Novello M.D., M.P.H., Dr.P.H. today announced fines totaling $48,000 -- the maximum amount permitted by law -- against Mt. Sinai Medical Center following a Department investigation into the January death of a 57 year old Saratoga County man who had undergone surgery to donate a portion of his liver to his ailing brother.

"Unfortunately, our investigation has concluded that the patient did not receive appropriate care following surgery," Dr. Novello said. "I can only describe the patient's post-operative care as fragmented at best, and entrusted to individuals who although qualified were unable to provide the level of attention necessary for his total post-operative care."

The patient died on January 13, 2002, three days after surgery as a living liver donor. The Health Department's investigation identified no problems during the operation itself. However, the investigation concluded that the patient was neither carefully monitored nor appropriately examined and evaluated post-surgery. Likewise significant changes in his condition on days following his transplant were not communicated to all those responsible for his care.

Among the investigation's findings:

  • During the weekend of January 12-13, 2002 the hospital's Transplantation Institute was inadequately staffed with nurses and physicians in charge of providing the necessary care for 34 transplant recipients and donors.
  • Post-operative rounds were found to be inadequate for monitoring and management of patients.
  • A first year surgical resident (PGY 1) was left alone for three hours on January 13 to care for all 34 patients. She described herself as feeling "overwhelmed" by the responsibility of caring for so many patients with only nurses to help her.
  • A first year Transplant Fellow failed to respond immediately when informed by the PGY 1 of a significant change in the patient's condition.
  • There was lack of communication among care-givers, both nursing and medical staff, regarding the patient's diet post-op.
  • Care-givers, including nursing staff and a fourth year surgical resident, also failed to promptly identify abnormal vital signs that would have allowed them to respond appropriately when the patient developed tachycardia (rapid heartbeat) and hiccups 48 hours post-op.

"The hospital allowed this patient to undergo a major, high-risk procedure and then left his postoperative care in the hands of an overburdened, mostly junior staff, without appropriate supervision" Dr. Novello said. "Supervision of medical residents was far too lax, resulting in woefully inadequate post-surgical care."

As a result of the investigation, the Health Department cited a total of 18 deficiencies against Mt. Sinai Medical Center under the categories of Governing Body, Medical Staff, Nursing Services, Patients' Right, Medical Records, Surgical Services and Critical Care and Special Care Services. State law permits a maximum fine of $2,000 per deficiency for 15 of these deficiencies and $6,000 for each of the deficiencies involving inadequate resident supervison. Regulations require the hospital to propose a specific corrective action for every deficiency cited, explaining in detail how each is to be addressed.

The hospital has cooperated in the investigation and has voluntarily suspended adult living liver donation procedures. The Department will require the suspension to remain in place for at least six months, pending verification that corrective actions have been implemented. The hospital also will be required to hire a consultant acceptable to the Department to look at both the adult and pediatric living liver transplant programs and identify any issues that remain to be resolved.

Approximately 170 living liver transplantation/donation procedures have been performed at Mt. Sinai since the program began in 1993. This is the first death to occur. Although the death was related to post-surgical care and not to the type of surgery, Dr. Novello will ask the New York State Transplant Council to review issues surrounding living liver donations. The Commissioner also is writing to the three other hospitals in New York that currently are performing living liver donation procedures to ensure that patients are receiving appropriate post-operative care and that post-graduate trainees are being appropriately supervised.

Time Line of Events

January 10, 2002

  • Patient undergoes surgery to remove the right lobe of his liver. No complications occur during procedure.

January 11, 2002

  • Patient is recovering; his condition is stable.

January 12, 2002

  • Patient is "examined" during rounds by first year Transplant Fellow and PGY 4 surgical resident. Transplant Fellow neither looks at, nor asks for patient's vital signs. At 4:00 p.m., patient develops tachycardia.

January 13, 2002

  • Approximately 1:00 a.m., patient develops hiccups and nausea. Patient is given medication to control symptoms, which may have masked the underlying problem.
  • 8:45 a.m., patient is examined by PGY4 surgical resident who is unaware of the patient's continuing tachycardia and nausea and previous hiccups and writes a progress note indicating that vital signs are stable.
  • 1:10 p.m., patient vomits brownish materials; tachycardia persists. PGY 1 surgical resident calls Transplant Fellow who is at a book store outside the hospital. He advises against insertion of a naso-gastric tube. Upon returning to the hospital, and despite the patient's distress, he does not examine him, but instead prepares a pre-operative work-up on another patient scheduled for surgery the next day.
  • 2:00 p.m., patient's oxygen saturation is unacceptably low; 100 percent oxygen is administered by mask.
  • 3:00 p.m., nurse calls PGY 1 resident to inform her that the patient is continuing to vomit and has difficulty breathing.
  • 3:10 p.m., patient becomes unconscious after vomiting more brownish materials and frank blood. Code is called; resuscitation measures are unsuccessful.
  • 3:40 p.m., patient is pronounced dead.

An autopsy revealed the presence of Clostridium perfringens infection in the patient's portal vein, esophagus, stomach, small intestine and lung. Clostridium perfringens is a bacteria that is normally present in the intestines of humans and animals, and is also found in soil and sewage. A separate investigation, looking into the source of the infection, is underway.

3/12/02–28 OPA